OHMEDA POSI-PULSE SUCTION UNIT— 510(k) K861261

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K861261 for OHMEDA POSI-PULSE SUCTION UNIT, Substantially Equivalent on 1986-05-30. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1986-04-04
Decision date: 1986-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.